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COVID-19 Update

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Bio/Pharma CMOs and CDMOs make business adjustments for pandemic; Image: MICROGEN - STOCK.ADOB.COM

CMOs and CDMOs: Pandemic and Beyond

COVID-19 and investments will shape the outsourcing industry for the near term.

Subunit Vaccines and the Fight Against COVID-19

Advances in technology are accelerating the development and manufacture of subunit vaccines.

Pfizer and BioNTech Release Phase III Trial Data Supporting Efficacy of Booster Doses

October 22, 2021

Pfizer and BioNTech’s Phase III trial demonstrated 95.6% booster efficacy relative to participants who received placebo.

EMA Approves Two New Manufacturing Sites and a New Formulation for Comirnaty

October 22, 2021

EMA's CHMP has approved two new manufacturing sites and a ready-to-use formulation of Comirnaty.

EMA Starts Evaluation of Comirnaty in Children

October 22, 2021

EMA has started its evaluation of further expanded use of Comirnaty in children aged between five years and 11 years old.

UK Government Announces Deal to Secure Two New COVID-19 Antivirals

October 22, 2021

UK government has secured two new antiviral treatments for COVID-19, which may be rolled out in a national clinical study before the end of 2021.

FDA Amends EUA to Allow Booster Shots for Moderna, J&J COVID-19 Vaccines

October 21, 2021

In addition to allowing booster shots of the Moderna and J&J vaccines, FDA approved heterologous booster shots.

Roche Submits Marketing Authorization Application for COVID-19 Treatment to EMA

October 14, 2021

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

EMA Ends Rolling Review of CureVac’s COVID-19 Vaccine Candidate

October 14, 2021

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

Smiths Detection Confirms BioFlash Detects Multiple Airborne SARS-CoV-2 Variants

October 13, 2021

Smiths Detection has confirmed that the Bioflash air sampler can detect Beta, Gamma, Kappa, Delta, and Delta plus variants.

AstraZeneca’s AZD7442 Clinical Trial Meets Primary Endpoint

October 12, 2021

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

Pfizer, BioNTech Request EUA for COVID-19 Vaccine in Children Aged 5-11

October 08, 2021

Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.